Australian Gold

Product NDC
58443-0437
11-digit product format
584430437
Labeler code
58443
Product ID
58443-0437_cf45d3d0-cd23-5878-e053-2995a90a14ca
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-12-11
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
29 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0437-458443043704237 mL in 1 TUBE (58443-0437-4) 237 ml2020-12-110000-00-00NoNoCurrent